Thomas V. Whalen, Surgeon Urges Silicone Implant Ban 

CAROL ANN CAMPBELL / Star-Ledger (NJ) 6nov03

Angering colleagues, N.J. doctor asks FDA to overrule his panel's vote

A controversial letter made public yesterday has thrust a New Jersey doctor into the center of the long-running debate over silicone breast implants.

Last month, a federal panel presided over by Thomas V. Whalen advised the government to allow the devices back on the market.

Now Whalen, a pediatric surgeon at the UMDNJ-Robert Wood Johnson Medical School in New Brunswick, has asked the federal Food and Drug Administration to overrule his own panel.

Whalen said he does not believe the long-term safety of the implants has been shown, and he said, in his letter to FDA Commissioner Mark McClellan, that he is concerned that the devices can eventually rupture and that they can obscure mammograms. He said many women require second operations because of leaking silicone.

Whalen's letter, the subject of an article in the Boston Globe yesterday, has elicited praise from those who called him courageous and criticism from those who said he has undermined the FDA's scientific approval process. Yet all agree his letter is highly unusual in the world of scientific committees whose behind-the-scenes deliberations steer medicine and science -- a world where cordiality generally reigns.

Whalen has especially angered plastic surgeons. Although he said he respected all members of the panel, he noted that the four plastic surgeons on the panel all voted in favor of the implants, and "it just does not play well in Peoria."

The vote was 9 to 6. The FDA is not bound to follow an advisory panel's recommendation but usually does.

As chair, Whalen could not vote -- unless there was a tie -- and he said he saw his role as that of a neutral moderator. He and the panel members listened to 100 people give testimony. In an interview yesterday, the doctor said he kept his opinions to himself during the hearing, but afterward found himself "unhappy and dissatisfied with the panel vote. ... I was amazed they voted in favor. The long-term safety was not demonstrated."

Critics said nothing prohibited Whalen from speaking up during the hearing.

"I think it is very wrong of him not to have spoken out if he had those opinions at the time. We were all very eager to hear what everyone on the panel thought," said Mary McGrath, a professor of surgery at the University of California, San Francisco. She performs breast surgery and voted in favor of the implants as long as the company petitioning for the approval, Inamed Corp., based in California, conducts long-term tracking of the women's health. The company must also give women information about the known risks, such as pain or breakage, the panel recommended.

McGrath said the four plastic surgeons on the panel did not collude and, in fact, were prevented from discussing the topic during lunch and other breaks. She said she resented the implication that plastic surgeons would benefit financially from approval of the implants. She said she gets paid the same whether she uses silicone or saline implants.

"To imply that I had financial gain is untrue," she said.

The American Society of Plastic Surgeons, based in Illinois, is not happy with Whelan's comments either.

"It's disingenuous at this time. He had control of the panel and every opportunity to speak," said James Wells, immediate-past president of the organization. "We object to his allegation that we had some financial benefit," he said.

To others, Whalen is a hero.

"This was a gutsy thing for him to do. It's brave," said Lynda Roth, founder of the Coalition of Silicone Survivors, a group based in Colorado. "It takes a lot for the panel director to come out against the panel. He must really feel like things are not right."

Roth said she had silicone implants in 1990 after breast cancer surgery and that the implants "ruptured and left my chest full of silicone." She said she has developed lupus and other auto-immune disorders because of the silicone.

Stories such as hers led to widespread press coverage about the implants in the early 1990s. Thousands of women joined class action lawsuits. The devices were pulled off the market in 1992. Yet some scientists have accused lawyers of using "junk science" in lawsuits.

Whalen's letter was specific and did not address controversial diseases that some link to silicone. He focused on the re-operation rates of women who have had leaking silicone. He said the complications were "not minor considerations for a cosmetic device." He said the long-term threat to women remains unknown and that Inamed must establish long-term safety.

Whalen said yesterday that he was surprised at the attention his letter has received.

"I am very confident that I did the right thing," he said.

source: http://www.nj.com/search/index.ssf?/base/news-11/106810209490300.xml?starledger?ntop 18nov03

image source: Breast Implant Risks FDA Nov00